Overview

Dose Escalation, Safety and Pharmacokinetic Study of SAR103168 in Patients Refractory/ Relapsed Acute Leukemias or High-risk Myelodysplastic Syndromes

Status:
Completed
Trial end date:
2012-02-01
Target enrollment:
Participant gender:
Summary
Primary objectives: - To determine the maximum tolerated dose (MTD) of SAR103168 and to characterize the dose limiting toxicities (DLTs) in the proposed dose regimen - To evaluate the pharmacokinetic (PK) profile of SAR103168 Secondary objectives: - To characterize the global safety profile of SAR103168 - To evaluate preliminary anti-leukemia activity - To investigate the potential induction effect on CYP3A4 and persistence of this effect by using oral midazolam as a probe substrate in patients enrolled into the expanded cohort at the MTD - To determine the metabolic pathways of SAR103168 and identify the chemical structures of metabolites - To determine the potential impact of SAR103168 on the QTc interval in patients enrolled at the MTD
Phase:
Phase 1
Details
Lead Sponsor:
Sanofi